Airway Management Via the Retromolar Route Access - a Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Comparison of vocal cord visualisation between the retromolar and the conventional method
研究概览
简要总结
Is there a difference in vocal cord visualization between the retromolar and conventional access?
详细描述
Management of the difficult airway is still an essential part of modern anaesthesia. Up to now, there have bee no clinical investigations comparing the intubation method via the retromolar route (RM), with the conventional intubation route (CM).
For the present clinical investigation, 100 patients undergoing elective surgery will be investigated in the General Hospital of Vienna when for the anaesthesia intubation is required. In both intubation methods (RM and CM) the anaesthesiologist will visually determine the Cormack & Lehane score in a randomly assigned sequence with and without a BURP-manoeuvre (= backwards, upwards and rightwards pressure). Thereafter intubation is performed in all patients by the CM method and if intubation fails the RM technique will be used. Of course, as per usual, every intubation trial is interrupted by a 20 second 100%-oxygen-ventilation period to reach a pulse oximetry oxygen saturation of at least 97% SpO2. Thereafter, if intubation fails again every other intubation technique will be applied, as necessary and called for.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18yr
- •BMI < 30kg/m2
- •Elective surgery
- •Absence of at least one molar of the right mandible
排除标准
- •Emergency patients
- •Prevalence of reflux disease
- •Toothless patients
- •Diaphragmatic hernia
- •Patient is not sober
- •Ventilation problems during induction of anaesthesia
- •Gastric regurgitation during induction of anaesthesia
- •Patient with a tracheostomy
结局指标
主要结局
Comparison of vocal cord visualisation between the retromolar and the conventional method
时间窗: After Intubation
In our present clinical trial we intend to compare the vocal cord visualisation by using the retromolar access compared to conventional intubation technique. Visualisation will be performed by randomized sequence and both methods will be performed in each patient. When no 100% visualisation of the vocal cords is achievable, a BURP (backward upward rightward pressure) manoeuvre will be performed. The same procedure will be performed for the another technique as well. For each trial, the anaesthesist has max. 30 seconds time for the vocal cord visualisation and scoring, which includes also the performance of the BURP-manoeuvre. Thereafter, and between each of the vocal cord visualizations as well, the patient will be ventilated by 100% oxygen for at least 20 seconds to reach at least 97% SpO2. Then intubation is performed in all patients by the conventional methode, and if intubation fails the retromolar technique, if possible.
次要结局
未报告次要终点
研究者
Wolfgang SCHRAMM
Ao Univ. Prof. Dr.
Medical University of Vienna